Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing

• Other Authors: Pörtner, Ralf (Editor), Möller, Johannes (Editor)
• Format: Electronic Book Chapter
• Language: English
• Published: Basel 2022
• Subjects: Technology: general issues; History of engineering & technology; clonal cell population; phenotypic diversity; inoculum train; uncertainty-based; cell culture model; biopharmaceutical manufacturing; Escherichia coli; hybrid modeling; machine learning; model-assisted DoE; quality by design; upstream bioprocessing; surface plasmon resonance (SPR); bioprocess; monitoring; biosensor; quality by design (QbD); process analytical technology (PAT); biotherapeutics production; vaccines production; CHO DP-12; computational fluid dynamics; bioreactor characterization; hydrodynamic gradients; process development; critical shear stress; Kolmogorov length scale; operational space; sensors; cell culture; spectroscopy; PAT; smart biomanufacturing; soft-sensor; Adeno-associated virus; transfection; PEI; continuous; gene therapy; microcarriers; bioreactor; transient expression; spheroid strength; β-cells; diabetes; shear stress-guided production; hydrodynamic stress; Gaussian processes; Bayes optimization; Pareto optimization; multi-objective; seed train; Chinese hamster ovary cells; cryopreservation; monoclonal antibodies; N−1 perfusion; process intensification; upstream processing; n/a
• Online Access: DOAB: download the publication; DOAB: description of the publication

Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as...